Autoimmune diseases are diseases in which the immune system of an organism attacks some or all of the organism's own cells and/or tissues. It is known that the symptoms of an autoimmune disease may be reduced, or eliminated, in some human patients by administration of drugs that inhibit the action of one or more of the components of the immune system responsible for attacking the body's own cells or tissues. The same drug(s) may not be effective, however, to improve the symptoms of an autoimmune disease in all human patients. There is no generally accepted explanation for why some autoimmune disease patients respond favorably to drug treatment, while others do not.
In an attempt to improve the symptoms of an autoimmune disease patient who does not respond favorably to a standard dose of medication, a physician may increase the dosage, and/or administer several medications. Some patients do not respond even to an increased dosage of medication, or to a combination of medications. These patients are therefore unnecessarily subjected to extensive medication which may cause undesirable side effects.
Similarly, human patients suffering from fibromyalgia show different levels of responsiveness to drug therapy. Fibromyalgia is a common disabling disorder characterized by chronic musculoskeletal aches and pain, stiffness, general fatigue, and sleep abnormalities including diminished stage four sleep. Examination of affected patients reveals increased tenderness at muscle and tendon insertion sites, known as “tender points”. Fibromyalgia patients experience severe morning stiffness and a generalized decrease in overall physical function, and they are often prone to headaches, memory and concentration problems, dizziness, numbness and tingling, and crampy abdominal or pelvic pain. Fibromyalgia affects 2–4% of the population and is most frequently found in women between 20 and 50 years old, though it can also affect men, the elderly and minors. Some human beings suffering from an autoimnune disease also suffer from fibromyalgia.
A physician can positively diagnose fibromyalgia syndrome by finding the symptoms of generalized musculoskeletal pain, and pain at more than 11 of 18 defined characteristic “tender points” when finger pressure of about 4 kg is applied to the area. The total pain score for all 18 tender points is referred to as the “tender point index” of that patient. The efficacy of a particular fibromyalgia therapy is demonstrated by observation of a statistically significant improvement in a patient's tender point index.
There is a need, therefore, to understand why some autoimmune disease patients, and patients suffering from fibromyalgia, do not respond favorably to standard medications; there is also a need for treatments that improve the symptoms of these patients; and there is a need for diagnostic tools and methods that permit identification of these patients, so that they are not unnecessarily prescribed medicines that do not improve the symptoms of their autoimmune disease, and/or fibromyalgia, and which may cause adverse side effects.